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Cole Werble

Washington, DC
Cole Werble is the former owner and editorial director of FDC Reports, Inc., the publisher of The Pink Sheet, The Gray Sheet, and other leading news publications for the health care industry. He has more than 35 years of experience analyzing business critical developments affecting the biopharma sector and developing world class information products for the sector.
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Latest From Cole Werble

Benefit-Risk Math: US FDA Still Favors Simple Calculations

A core group of big pharma companies has been pressing FDA for over a decade to adopt a quantitative formula for conducting and communicating benefit-risk decisions. FDA has changed its benefit-risk calculations in response – but not its basic way of doing the math.
Drug Approval Standards Drug Review

US FDA “Enriches” Trial Guidance With Recent Examples

Illustrating that principles articulated in 2012 draft are being broadly accepted at FDA, final guidance on enrichment strategies for clinical trials adds new examples from across the agency’s drug review divisions.
Clinical Trials Drug Approval Standards

Gilead Has Full HIV Policy Agenda For 2019: Part D Challenge; Prophylaxis Increase

Gilead faces two-pronged policy challenge in its core HIV business: its Part D product line could lose protections, but prophylactic prescriptions could dramatically expand under the Trump Administration's plan to eliminate HIV transmission.
Medicare Policy

FDA’s Sentinel Strategy: Starting Slow Move Toward “Active” Surveillance

US FDA’s strategic plan for Sentinel includes pilot projects to move towards the vision of active surveillance. However, FDA is also making clear that it won’t be a quick or easy transformation. 
Drug Safety Post Market Regulation & Studies

Civica Rx's Strategy To Reduce Drug Shortages Focuses On Guaranteed-Price Contracts

Non-profit intermediary being built by hospitals and health systems offers a private sector response to one of the deterrents to adequate supplies of important older generic drugs. 
Generic Drugs Manufacturing

Counter-Intuitive Thinking To Combat Drug Shortages

Search for solutions to chronic drug shortages may require policymakers to push for payment policies that run counter to the current drug pricing themes, like retrofitting US Medicare’s New Technology Add-On Payments to apply to old, off-patent therapies.
Generic Drugs Manufacturing
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